FDA official: Core inspectional functions, priorities unchanged despite leadership changes

The core mission of the US Food and Drug Administration’s (FDA) inspections program, as well as how it prioritizes inspections, has remains unchanged despite recent leadership changes at the agency, said Ivy Sweeney, deputy director of the Office of Human and Animal Drug Inspectorate (OHADI).

Sweeney also mentioned that FDA currently has 200 inspectors dedicated to the human and animal drug program and plans to hire 45 more to enhance the agency's capacity for conducting inspections, particularly at foreign sites.

Sweeney provided an update on the agency's inspection priorities during the 50th International GMP Conference, held in Athens, Georgia. The conference is sponsored by the FDA and the University of Georgia School of Pharmacy.

“A lot has been going on at FDA. We don’t talk about all the changes that are occurring,” she said. “One of the reasons why we don’t talk about all this is that our core functions have not changed. FDA’s priorities on inspections have not changed. Our inspectorate and how we conduct inspections has not changed. The expectation for oversight has not changed. What has changed is the leadership. We have changes in administrative support but for the most part, I can’t express more that our staff continues to be dedicated to its work in the inspectorate.”

She said that OHADI has three priorities: conducting risk-based inspections, preapproval inspections, and surveillance inspections. Sweeney said that the agency has not been able to conduct surveillance inspections at plants every two years because of its focus on risk-based inspections. “There is less predictability about when we will come but at some point, we will come,” she said.

Another priority is to increase the number of foreign unannounced infections. Sweeney told the gathering that “we are ramping up our unannounced inspections for foreign facilities.”

She explained that efforts to increase inspections overseas build on two existing programs: the unannounced inspection pilot in China and India, and a recent initiative to expand unannounced inspections launched in May 2025. (RELATED: FDA to expand unannounced foreign inspections after Trump executive order, Regulatory Focus 6 May 2025)

The unannounced inspection pilot program began in March 2022 and targets human drug manufacturing facilities in India and China. As of now, the FDA has completed approximately 62% of the planned inspections for these sites. This pilot program was announced by the FDA in December 2021. (RELATED: Unannounced FDA inspections in India, China to begin soon, Regulatory Focus 15 December 2019)

The pilot was launched to address concerns from government officials about the COVID-19 pandemic’s toll on FDA’s foreign inspection program. In a March 2021 report, the GAO warned a House Appropriations Subcommittee that the agency needs to come up with a plan to address the looming inspection backlog and tackle some of its longstanding issues. (RELATED: FDA’s inspection backlog: GAO raises concern as delays mount, Regulatory Focus 9 March 2021)

What to expect during an inspection

Sweeney also discussed what manufacturers can inspect during an inspection and what questions the FDA will ask.

Inspectors typically arrive during regular operating hours and will ask to speak with the most responsible person on-site. They will present a Form FDA 482, which is a notice of inspection, along with their credentials. The inspectors will then examine the production floor and operations, review procedures and records, and hold daily wrap-up meetings to discuss their findings.

Sweeney said that “our workforce is very highly skilled and is expected to be able to inspect a wide variety of facilities and they must be prepared and must be responsive to investigate signals such as field alerts.”

Sweeney said that “despite hiring freezes in certain areas, FDA is continuing to actively recruit investigators. We have just over 200 staff right now and we anticipate adding maybe 45 or more over the next year or so. We are continuing to invest and to recruit and that will allow us to meet our current work plan and allow us to expand our foreign unannounced inspections.”

FDA official: Core inspectional functions, priorities unchanged despite leadership changes

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